- Atrium Health (Charlotte, NC)
- …2020and a dedicated COVID-19 medical-surgical unit was needed, the first choice by senior leadershipwas 10 Tower.This has been a challenge that we have met with ... Health. 10T Medical Telemetry is a recipient of the PRISM award (Premier Recognition in the Specialty of Med/Surg) from the Academy of Medical/Surgical Nurses, given… more
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. . Lead or contribute to development… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...Manager : Requires 7+ years of relevant experience + Senior Manager : Requires 8+ years of relevant… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic... Manager , Manager & Associate III). The Sr Director, Regulatory Affairs CMC is ... and new people to make a difference with. **The opportunity** The Sr . Director, Global Regulatory Affairs CMC is responsible to oversee and help develop… more
- Charles River Laboratories (Rockville, MD)
- …help you build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. ... through mapping resource across projects. In this role, the Senior CMC Project Manager is...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- BeiGene (San Mateo, CA)
- **General Description:** Sr . Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more
- Taiho Oncology (Princeton, NJ)
- …procurement operations and external supplier development and management. Position Summary: Senior Manager , Outsourcing and Vendor Management, supports and ... Sr . Manager , Outsourcing & Vendor Management...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- Amazon (North Reading, MA)
- …support a well-established yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * ... Description We are seeking a Senior Manager for our functional safety...Engineering, Technical Program Management, Advanced Quality Planning, Safety & Regulatory Compliance, Reliability, Strategic Sourcing and Design for Assembly.… more
- Leidos (Bethesda, MD)
- …a plus, with experience that may include but is not limited to research, CMC , clinical, regulatory , or other relevant roles at biotechnology or pharmaceutical ... **Description** Leidos Health and Civil Sector is seeking a Sr . Scientist/Engineer to support an exciting Healthcare program. Preference...that may include but is not limited to research, CMC , clinical, regulatory , or other relevant roles… more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. This ** Senior Manager , Quality Operations** will manage and provide oversight on ... understand quality system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management to achieve alignment… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Sr Manager , Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting ... monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing,...include the following:** + Serves as lead drug supply manager of a program and/or individual studies for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a Scientific ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for...in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs. Key Responsibilities +… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... and support the generation of appropriate responses to questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... the Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality, regulatory , project management, legal, sourcing, supply ... team based in Watertown, MA and report to the manager of the drug product outsourcing group. The team...team player. + Experienced in writing, reviewing, and approving CMC sections of regulatory filings from early-stage… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Merck (Boston, MA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... supplies. + Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
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